Study to Determine Results of Vibratory Stimulus on Subject's Neck

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kai Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01491828
First received: December 10, 2011
Last updated: March 19, 2012
Last verified: December 2011

December 10, 2011
March 19, 2012
November 2011
January 2012   (final data collection date for primary outcome measure)
Head, neck, or jaw movement [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Movement of head, neck, or jaw as evidenced by manual observation and video camera.
Same as current
Complete list of historical versions of study NCT01491828 on ClinicalTrials.gov Archive Site
Affect of sleep stage [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Electrocortical arousal caused by device as measured by EEG.
Same as current
Not Provided
Not Provided
 
Study to Determine Results of Vibratory Stimulus on Subject's Neck
Study to Determine Results of Vibratory Stimulus on Subject's Neck

This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.

This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement, and provide information regarding the optimum location and variable vibration parameters of vibratory stimulus on a subject's neck to cause head, neck, or jaw movement. The study will also provide information whether the subject experienced or did not experience a change in sleep stage or arousal by vibratory stimulus on a subject's neck. The data gathered from this study will be used for future studies in analyzing whether such vibratory stimulus can serve as a potential treatment for sleep disorders, such as snoring and obstructive sleep apnea.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Sleep Apnea
  • Snoring
Device: Kai Strap
Medical device component that vibrates on a subject's neck.
Other Name: Kai Patch
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, ages 18 to 80 years old
  • Able to provide written informed consent for themselves and comply with study procedures.

Exclusion Criteria:

  • Known hyposensitivity or hypersensitivity to vibrations on neck.
  • Neurological disorder such as seizure disorder or narcolepsy.
  • Psychiatric disorders currently not under control.
  • Insomniacs.
  • Pregnant women.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01491828
400
No
Kai Medical, Inc.
Kai Medical, Inc.
Not Provided
Principal Investigator: Kelley Ford Shippey III, MD, MS
Kai Medical, Inc.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP